A Phase I Single and Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of HS-10522 in Healthy Chinese Participants and Chinese Participants With Mild Hypertension

Официальное название

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HS-10522 Tablets in Healthy Chinese Participants and Chinese Participants With Mild Hypertension

Обзор

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension.

Вмешательства

• Препарат HS-10522
  HS-10522 tablet, oral, single ascending dose and multiple ascending dose, once daily
• Препарат HS-10522 Placebo
  HS-10522 placebo , oral, single ascending dose and multiple ascending dose, once daily

Первичные конечные точки

• Incidence of adverse events following single and multiple doses of HS-10522 in healthy participants and participants with mild hypertension [Срок оценки: SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing]

Вторичные конечные точки (10)

• Maximum plasma concentration (Cmax) [Срок оценки: -0.5 to 120 hour after dosing]
• time to maximum plasma concentration (Tmax) [Срок оценки: -0.5 to 120 hour after dosing]
• area under the curve (AUC) [Срок оценки: -0.5 to 120 hour after dosing]
• half-life [Срок оценки: -0.5 to 120 hour after dosing]
• apparent volume of distribution (Vz/F) [Срок оценки: -0.5 to 120 hour after dosing]
• apparent oral clearance (CL/F) of HS-10522 [Срок оценки: -0.5 to 120 hour after dosing]
• Plasma aldosterone following single and multiple oral doses of HS-10522 [Срок оценки: 0 to 96 hour after dosing]
• Cortisol following single and multiple oral doses of HS-10522 [Срок оценки: 0 to 96 hour after dosing]
• Metabolites levels following single and multiple oral doses of HS-10522 [Срок оценки: 0 to 96 hour after dosing]
• (Exploratory) Mean seated systolic and diastolic blood pressure change compared with baseline [Срок оценки: 14 days after dosing]

Критерии участия

Критерии включения

\-

For all participants:

• Able to understand the procedures and methods of the study, willing to strictly adhere to the clinical trial protocol to complete the study, and voluntarily sign the Informed Consent Form (ICF).
• Male or female participants aged 18 to 55 years (inclusive) at the time of signing ICF.
• At screening, body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive).

Критерии исключения

• Abnormal vital signs, physical examination findings, or laboratory test results at screening that are deemed clinically significant by the investigator.
• Presence of orthostatic hypotension or orthostatic tachycardia at screening.
• Clinically significant abnormal findings on the 12-lead ECG at screening, as judged by the investigator.
• Use of any medication within 2 weeks or 5 half-lives (whichever is longer) prior to screening, or anticipation of needing such medication during the trial.
• Known secondary causes of hypertension, or diseases that may affect adrenal function (e.g., renal artery stenosis, poorly controlled or untreated hyperthyroidism, poorly controlled or untreated hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome).
• Participation in any other clinical trial of a drug or medical device within 12 weeks prior to screening, with receipt of at least one dose (including placebo), or currently within 5 half-lives of the last dose of the investigational product (whichever is longer).
• Participants who, in the opinion of the investigator, are likely to be non-compliant or are unsuitable for participation in this trial for any other reason.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07609875 · HS-10522-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗